A FHIR® has been lit on gICS® – Facilitating the standardized exchange of informed consents in a large network of university medicine (NUM) in pandemic research

Abstract Background The Federal Ministry of Education and Research (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The “COVID-19 Data Exchange Platform” (CODEX) as part of NUM establishes a harmonised infrastructure that supports decentral but standardised provision as well as federated combination and research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for such data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7® FHIR® consent profiles and the interoperability concept of the MII Task Force “Consent Implementation” (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald successfully supports data protection-compliant data processing in various research projects since 2014 and provides the consent management solutions gICS®, which supports fully digital and paper-based consent management. Results A “TTP-FHIR Gateway” for the HL7® FHIR®-compliant exchange of consent information using gICS® throughout NUM-CODEX was implemented and provided to all NUM sites in June 2021 as a separate software component. The gateway relies on the gICS® application logic. All FHIR® functionalities comply with the already-balloted FHIR® consent profiles of the HL7® Working Group Consent Management. A pre-configured consent template for the BC is provided to all NUM sites, thereby simplifying the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites. Conclusions This article proves that a HL7® FHIR®-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS® and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.